EGFR promotes cell growth in normal epithelial tissues including the skin and is expressed on a variety of tumour cells. The EGFR inhibitors, cetuximab (Erbitux), erlotinib (Tarceva▼), gefitinib (Iressa▼) and panitumumab (Vectibix▼), are used to treat EGFR-expressing tumours.

Reports of keratitis and ulcerative keratitis

The cornea is covered with a layer of epithelium which may be damaged by treatment with EGFR inhibitors. Patients with a history of keratitis, ulcerative keratitis or severe dry eye may be particularly at risk. Serious cases of keratitis and ulcerative keratitis (corneal ulceration) have been reported with varying frequency following treatment with an EGFR inhibitor. In rare cases, this has led to corneal perforation and blindness. Ulcerative keratitis must therefore be regarded as an ophthalmological emergency.

This issue was first identified with panitumumab (Vectibix) and a letter sent to healthcare professionals in May 2011. The risk of keratitis and severe keratitis is now considered a class effect for all EGFR inhibitors, and information for all products in this class has been updated with warnings on this risk.

Advice for healthcare professionals:

ulcerative keratitis is an opthalmological emergency

patients undergoing treatment with EGFR inhibitors who present with acute or worsening signs and symptoms suggestive of keratitis such as:

eye inflammation

increased lacrimation

light sensitivity

blurred vision

eye pain and/or red eye should be referred promptly to an ophthalmology specialist

if a diagnosis of ulcerative keratitis is confirmed, treatment with the EGFR inhibitor should be interrupted or discontinued

Patients with a history of keratitis, ulcerative keratitis or severe dry eye may be particularly at risk of ocular damage with EGFR inhibitors.